The Recall Desk

FDA (Devices) recall action 80169

Angiodynamics Inc. (Navilyst Medical Inc.) recalled 38 products on 2018-06-20

The FDA (Devices) publishes a recall like this one as 38 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 38 pages.

Products
38
Announced
2018-06-20
Critical
0
Units
1,911

Why these products were recalled

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–38 of 38